Cleared Traditional

PLANMECA INTRACAM

K972033 · Planmeca Oy · Dental
Jun 1997
Decision
18d
Days
Class 1
Risk

About This 510(k) Submission

K972033 is an FDA 510(k) clearance for the PLANMECA INTRACAM, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Planmeca Oy (Helsinki, FI). The FDA issued a Cleared decision on June 20, 1997, 18 days after receiving the submission on June 2, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K972033 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1997
Decision Date June 20, 1997
Days to Decision 18 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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